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Completed Not applicable Interventional Results available

Safety and Clinical Performance of the Protecta ICD and CRT-D

ClinicalTrials.gov ID: NCT00982397

Public ClinicalTrials.gov record NCT00982397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 11:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The PainFree SST Clinical Study: Clinical Study to Evaluate System Safety and Clinical Performance of the Protecta ICD + CRT-D and to Assess the Capacity of the Protecta Features to Reduce Inappropriate Shocks.

Study identification

NCT ID
NCT00982397
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Industry
Enrollment
2,770 participants

Conditions and interventions

Interventions

  • Protecta VR-ICD Device
  • Protecta DR-ICD or CRT-D Device

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2009
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013
Last update posted
Nov 5, 2017

2009 – 2013

United States locations

U.S. sites
29
U.S. states
21
U.S. cities
29
Facility City State ZIP Site status
Birmingham Heart Clinic PC Birmingham Alabama 35235
CardioVasular Associates of Mesa Mesa Arizona 85206
Mercy Hospital Fort Smith Fort Smith Arkansas 72903
LA Cardiology Associates Los Angeles California 90017
Cardiology Consultants of Napa Valley Napa California 94558
Hartford Hospital Hartford Connecticut 06102
University of Florida Health at Jacksonville Jacksonville Florida 32209
Arrhythmia Syncope Consultants LLC Miami Florida 33133
Indiana Heart Physicians Indianapolis Indiana 46237
Cardiovascular Research of Northwest Indiana Munster Indiana 46321
Iowa Heart Center West Des Moines Iowa 50314
Delmarva Heart Research Foundation Salisbury Maryland 21804
Essentia Institute of Rural Health Duluth Minnesota 55805
CentraCare Heart & Vascular Center Saint Cloud Minnesota 56303
Saint John's Medical Research Inc Springfield Missouri 65804
Saint Louis Heart & Vascular PC St Louis Missouri 62040
Cardiology PC Syracuse New York 13210
Pinehurst Medical Clinic Pinehurst North Carolina 28374
Ohio Heart and Vascular Cincinnati Ohio 45219
St. Vincent Mercy Medical Center Toledo Ohio 43608
Central Bucks Cardiology Doylestown Pennsylvania 18901
University of Pennsylvania Philadelphia Pennsylvania 19104
Pee Dee Cardiology Florence South Carolina 29506
Cardiology Consultants PA Spartanburg South Carolina 29303
Centennial Heart Cardiovascular Consultants LLC Nashville Tennessee 37203
Hall-Garcia Cardiology Associates Houston Texas 77030
Virginia Commonwealth University Health System Richmond Virginia 23298
Spokane Cardiology Spokane Washington 99204
Columbia St. Mary's Hospital Milwaukee Wisconsin 53211

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 93 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00982397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 5, 2017 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00982397 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →